SOMERSET
QC Scientist (Raw Materials)
We usually respond within a week
Introduction to Ardena
As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizesfrom emerging biotech to global industry leadersunited by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support.
With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locationsBelgium (Ghent), the Netherlands (Oss and Assen), Sweden (Sodertalje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team.
We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you're an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us.
If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you.
For the Ardena Business Unit based in Somerset (US), we are looking for a QC Scientist (Raw Materials).
WHAT YOU WILL WORK ON
YOUR ROLE
The Scientist works with others, for the successful and timely testing of new and commercial pharmaceutical products using conventional, current and new analytical technologies to support formulation development and for the quality control of raw materials, intermediates, finished product and stability samples by analyzing data and interpreting results, and communicating findings through reports for the development of new and existing products.
YOUR KEY RESPONSIBILITIES
Conducts QC activities required for the timely completion of sample analysis associated with raw material, in-process, finished product and stability test samples.
Independently completes assigned projects and activities to meet agreed milestones and deliverables for clinical and commercial manufacture.
Analytical techniques used include but are not limited; Chromatographic analysis, dissolution testing and standard wet chemistry using conventional methods of analysis, instrumentation and electronic systems including where applicable CDMS, LIMS and ELN.
Conducts and documents laboratory investigations and deviations.
Prepares reports and presentations, verbal and written on project progress; authors and reviews test methods, reports, protocols, SOPs and specifications.
YOUR PROFILE
AS Chemistry/Analytical Chemistry with 5+ years of experience in analytical support of pharmaceutical product manufacture and development OR
BS Chemistry/Analytical Chemistry with 3+ years of experience in analytical support of pharmaceutical product manufacture and development
Experience and knowledge of scientific principles and concepts and analytical instrumentation.
In-depth knowledge of ICH guidelines, USP/EP/JP standards, and global regulatory expectations (FDA, EMA, etc.).
Extensive experience with compendial testing (USP/EP/JP) and method verification.
Individual maybe required to occasionally lift 0-15 pounds and will access GMP laboratory and plant and office areas.
Soft skills that align with our CARE values- Communicative, Accountable, Reliable, and Excellent.
WHAT WE OFFER
At Ardena, we recognize that our people drive our success. We offer:
A competitive salary with a tailor-made benefits package, including: medical, dental and vision benefits effective day one of employment
Salary Range - $72,000.00-$83,500.00
Paid Time Off
A dynamic, global work environment with career growth opportunities
Access to Ardena Academy, our internal learning platform for professional development
A chance to contribute to groundbreaking drug development projects that make a real impact
QC Scientist (Raw Materials)
We usually respond within a week
Introduction to Ardena
As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizesfrom emerging biotech to global industry leadersunited by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support.
With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locationsBelgium (Ghent), the Netherlands (Oss and Assen), Sweden (Sodertalje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team.
We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you're an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us.
If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you.
For the Ardena Business Unit based in Somerset (US), we are looking for a QC Scientist (Raw Materials).
WHAT YOU WILL WORK ON
YOUR ROLE
The Scientist works with others, for the successful and timely testing of new and commercial pharmaceutical products using conventional, current and new analytical technologies to support formulation development and for the quality control of raw materials, intermediates, finished product and stability samples by analyzing data and interpreting results, and communicating findings through reports for the development of new and existing products.
YOUR KEY RESPONSIBILITIES
Conducts QC activities required for the timely completion of sample analysis associated with raw material, in-process, finished product and stability test samples.
Independently completes assigned projects and activities to meet agreed milestones and deliverables for clinical and commercial manufacture.
Analytical techniques used include but are not limited; Chromatographic analysis, dissolution testing and standard wet chemistry using conventional methods of analysis, instrumentation and electronic systems including where applicable CDMS, LIMS and ELN.
Conducts and documents laboratory investigations and deviations.
Prepares reports and presentations, verbal and written on project progress; authors and reviews test methods, reports, protocols, SOPs and specifications.
YOUR PROFILE
AS Chemistry/Analytical Chemistry with 5+ years of experience in analytical support of pharmaceutical product manufacture and development OR
BS Chemistry/Analytical Chemistry with 3+ years of experience in analytical support of pharmaceutical product manufacture and development
Experience and knowledge of scientific principles and concepts and analytical instrumentation.
In-depth knowledge of ICH guidelines, USP/EP/JP standards, and global regulatory expectations (FDA, EMA, etc.).
Extensive experience with compendial testing (USP/EP/JP) and method verification.
Individual maybe required to occasionally lift 0-15 pounds and will access GMP laboratory and plant and office areas.
Soft skills that align with our CARE values- Communicative, Accountable, Reliable, and Excellent.
WHAT WE OFFER
At Ardena, we recognize that our people drive our success. We offer:
A competitive salary with a tailor-made benefits package, including: medical, dental and vision benefits effective day one of employment
Salary Range - $72,000.00-$83,500.00
Paid Time Off
A dynamic, global work environment with career growth opportunities
Access to Ardena Academy, our internal learning platform for professional development
A chance to contribute to groundbreaking drug development projects that make a real impact
Job ID: 483931283
Originally Posted on: 7/3/2025
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